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Recall Observatory FDA recall evidence

Device product

Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating patients and used with a ventilator to provide oxygen or anesthetic agents to the patient.

Z-2243-2016

June 02, 2016

Class II

Product summary

Firm
Parker Medical
Event
Event 74547
Status
Terminated
Classification
Class II
Quantity
5,500 units
Official record key
device-enforcement:Z-2243-2016

Official wording

Reason: Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal tube,with Parker Flex-Tip,Sub-Glottic Suction, High Volume low Pressure) due to tube kinking during use.

Code information: Model Number: H-PFTVPU-60; H-PFTVPU-65; H-PFTVPU-70; H-PFTVPU-75; H-PFTVPU-80; H-PFTVPU-85; H-PFTVPU-90; H-PFTVVC-60; H-PFTVVC-65; H-PFTVVC-70; H-PFTVVC-75; H-PFTVVC-80; H-PFTVVC-85; H-PFTVVC-90 Lot Numbers: 1512TVC2029I through 1512TVC2029O (I, J, K, L, M, N, O); 1602TVC0226I through 1602TVC2226O (I, J, K, L, M, N, O); 1602TVU0226I through 1602TVU0226O (I, J, K, L, M, N,O); 1512TVU2029I through 1512TVU2029O (I, J, K, L, M, N,O)

Distribution pattern: US Nationwide Distribution in the states of KY, MO, FL, TN, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal tube,with Parker Flex-Tip,Sub-Glottic Suction, High Volume low Pressure) due to tube kinking during use.